Legal claims defining the scope of protection. Each claim is shown in both the original legal language and a plain English translation.
1. A method of on-body fluid delivery using a primary user interface communicatively couplable to a primary patch pump comprising a first reservoir adapted to contain a first fluid, a first cannula, a first pump adapted to infuse the first fluid from the first reservoir through the first cannula, and a first microcontroller adapted to control operations of the first pump, the method comprising the steps of: attaching a primary patch pump to a user's skin at an attachments site; inserting the first cannula into the attachment site through a surface of the primary patch pump attached to the user's skin; pairing the primary patch pump for remote wireless communication via a wireless communication interface to a primary user interface; communicating via the wireless communication interface between the primary patch pump and the primary user interface to determine whether user instructions have been received at the primary user interface; and if it is determined that user instructions have been received at the primary user interface: sending machine instructions from the primary user interface to the primary patch pump via the wireless communication interface according to the user instructions; and initiating a bolus dose or basal rate using the first microcontroller according to the machine instructions; checking by the primary patch pump for an error condition; if an error condition is detected by the primary patch pump, alerting a user via an alert mechanism and transferring relevant data from the primary patch pump to the primary user interface; if no error condition is detected by the primary patch pump, transferring relevant data from the primary patch pump to the primary user interface, and returning to the step of the primary patch pump communicating with the primary user interface; checking whether communication with the primary user interface was successful; if communication with the primary user interface was not successful, deploying a second catheter from a second pump and continuing infusion with the second pump.
Medical device technology for on-body fluid delivery. This invention addresses the need for reliable and user-controlled fluid infusion, particularly in situations where primary system failure might occur. The system involves a primary patch pump designed to be attached to a user's skin. This patch pump contains a reservoir for a fluid, a cannula for infusion, a pump mechanism, and a microcontroller to manage operations. A separate primary user interface is communicatively linked to the patch pump, typically via wireless communication. The method begins with attaching the patch pump to the skin and inserting its cannula. The patch pump is then paired with the user interface for remote control. The user interface monitors for incoming user instructions. Upon receiving instructions, the user interface sends corresponding machine instructions to the patch pump. The patch pump's microcontroller then initiates a fluid delivery, such as a bolus dose or basal rate, based on these machine instructions. Crucially, the patch pump performs an error check after receiving instructions. If an error is detected, the user is alerted, and relevant data is sent to the user interface. If no error is found, data is still transferred to the user interface. If communication with the user interface fails at any point, a backup system is activated: a second catheter is deployed from a second pump, and infusion continues using this secondary pump.
2. The method of on-body fluid delivery of claim 1 , wherein an error condition comprises a condition indicative of at least one of a cannula occlusion, a low reservoir, an end of reservoir, a depleted battery, a battery failure, a cannula deployment, entrapped air and a leakage.
This invention relates to on-body fluid delivery systems, specifically methods for detecting and handling error conditions during fluid administration. The system monitors various parameters to identify issues such as cannula occlusion, low or depleted reservoir levels, battery failures, cannula deployment problems, entrapped air, or leakage. When an error condition is detected, the system triggers an appropriate response, such as pausing delivery, alerting the user, or initiating corrective actions. The method ensures safe and reliable fluid delivery by continuously assessing these conditions to prevent complications like incomplete dosing or system malfunctions. This approach enhances patient safety and system reliability in medical devices designed for continuous or intermittent fluid administration.
3. The method of on-body fluid delivery of claim 1 , wherein relevant data comprise data indicative of at least one an infusion profile update, an infusion command, a bolus dose, a bolus dose requirement, a basal rate, a basal rate adjustment, a confirmation of delivery, an error state or condition, and a confirmation of adjustment.
This invention relates to on-body fluid delivery systems, specifically methods for transmitting relevant data between a fluid delivery device and an external controller or monitoring system. The technology addresses the need for efficient and reliable communication of critical information in medical infusion systems, such as insulin pumps or other drug delivery devices, to ensure accurate dosing and patient safety. The method involves transmitting data indicative of various infusion parameters and states, including infusion profile updates, infusion commands, bolus doses, bolus dose requirements, basal rates, basal rate adjustments, delivery confirmations, error states or conditions, and adjustment confirmations. These data types are essential for real-time monitoring and control of fluid delivery, allowing healthcare providers or automated systems to verify proper operation, detect errors, and make necessary adjustments. The communication ensures that the fluid delivery device operates according to prescribed parameters while providing feedback to the user or controller to maintain therapeutic efficacy and safety. The method enhances the reliability of on-body fluid delivery systems by ensuring timely and accurate transmission of critical operational data.
4. The method of on-body fluid delivery of claim 1 , wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump.
This invention relates to on-body fluid delivery systems, specifically patch pumps, which are wearable devices for administering fluids such as insulin to a patient. The primary challenge addressed is ensuring reliable communication and synchronization between the primary user interface (e.g., a handheld controller) and the patch pump to prevent dosing errors or interruptions in therapy. The system includes a primary user interface that communicates wirelessly with a primary patch pump attached to the patient's body. The patch pump delivers fluid doses based on commands from the user interface. To maintain accurate synchronization, the primary user interface periodically re-synchronizes with the patch pump. This re-synchronization process ensures that both devices share the same operational state, including dose history, remaining fluid volume, and any pending commands. The re-synchronization may occur automatically at scheduled intervals or in response to specific events, such as a detected communication error or a user-initiated request. This feature helps prevent discrepancies between the user interface and the patch pump, reducing the risk of incorrect dosing or therapy interruptions. The system may also include additional patch pumps and user interfaces, with the primary devices managing synchronization across the network.
5. The method of on-body fluid delivery of claim 4 , wherein the primary user interface re-synchronizes the primary user interface and the primary patch pump using a real-time clock.
This invention relates to on-body fluid delivery systems, specifically patch pumps, which are wearable devices for administering fluids such as insulin or other medications. A common challenge in such systems is maintaining synchronization between the primary user interface (e.g., a smartphone or controller) and the patch pump to ensure accurate dosing and timing. If synchronization is lost, dosing errors or delays can occur, potentially compromising treatment efficacy or safety. The invention addresses this problem by incorporating a real-time clock in the primary user interface to re-synchronize the interface and the patch pump. The real-time clock allows the system to periodically or automatically verify and correct timing discrepancies between the two components. This ensures that the patch pump operates according to the intended schedule, even if communication interruptions or other disruptions occur. The synchronization process may involve time-stamped data exchanges or other clock-based verification methods to confirm alignment. By maintaining precise timing, the system improves reliability and reduces the risk of dosing errors, which is critical for therapies requiring strict adherence to schedules. This solution is particularly useful in medical applications where accurate and timely fluid delivery is essential.
6. The method of on-body fluid delivery of claim 1 , wherein pairing the primary patch pump to the primary user interface comprises assigning a first unique identifier to the primary user interface and a second unique identifier to the primary patch pump.
This invention relates to on-body fluid delivery systems, specifically improving the pairing process between a primary patch pump and a primary user interface to ensure accurate and secure fluid delivery. The system addresses the challenge of reliably connecting a wearable patch pump to a user interface device, such as a smartphone or controller, to prevent mispairing and ensure proper medication or fluid administration. The method involves assigning a first unique identifier to the primary user interface and a second unique identifier to the primary patch pump. These identifiers facilitate secure and unambiguous pairing between the devices, reducing the risk of errors during setup or operation. The patch pump is a wearable device that delivers fluids, such as medications, directly to the body, while the user interface allows users to monitor and control the pump's functions. The unique identifiers ensure that only the intended devices communicate with each other, enhancing safety and reliability in medical applications. This pairing mechanism is particularly useful in healthcare settings where precise and error-free fluid delivery is critical.
7. The method of on-body fluid delivery of claim 1 , further comprising the step of: entering a primary patch pump SNIFF mode for up to a predetermined primary patch pump SNIFF time to check for an error condition.
This invention relates to on-body fluid delivery systems, specifically patch pumps used for controlled administration of fluids such as medications. The problem addressed is ensuring accurate and safe fluid delivery by detecting potential error conditions before or during operation. The system includes a primary patch pump designed to deliver fluid to a user's body. To enhance reliability, the pump enters a "SNIFF mode" for a predetermined duration, during which it checks for error conditions that could affect performance. This mode involves monitoring system parameters such as pressure, flow rate, or sensor readings to identify malfunctions like blockages, leaks, or mechanical failures. If an error is detected, the system may trigger an alert or halt operation to prevent incorrect dosing. The SNIFF mode operates independently of other system functions, ensuring continuous monitoring without disrupting fluid delivery. This feature improves safety by proactively identifying issues before they compromise therapy. The invention is particularly useful in medical devices requiring precise and reliable fluid administration, such as insulin pumps or pain management systems.
8. The method of on-body fluid delivery of claim 1 , wherein the primary patch pump is attachable to skin.
The invention relates to a system for delivering fluids to the body, specifically an on-body fluid delivery device designed to be attached directly to the skin. The primary patch pump is a compact, wearable device that adheres to the skin and is capable of delivering controlled doses of fluid, such as medications or other therapeutic substances, directly into the body. The device is designed to be portable and discreet, allowing users to carry out their daily activities without interruption. The patch pump may include mechanisms for precise fluid dosing, such as a pump or valve system, and may be controlled electronically to ensure accurate and consistent delivery. The system may also incorporate sensors to monitor fluid levels, delivery rates, or other relevant parameters, providing feedback to the user or a healthcare provider. The device is intended to improve convenience and compliance for patients requiring regular fluid administration, reducing the need for frequent injections or infusions. The patch pump may be reusable or disposable, depending on the design, and may be compatible with various types of fluids, including insulin, pain medications, or other therapeutic agents. The invention aims to provide a reliable, user-friendly solution for on-body fluid delivery, enhancing patient comfort and treatment adherence.
9. The method of on-body fluid delivery of claim 1 , wherein the first fluid comprises insulin.
This invention relates to on-body fluid delivery systems, specifically for administering insulin to a patient. The system includes a wearable device that stores and delivers insulin to the body through a subcutaneous or transdermal interface. The device is designed to provide controlled, precise dosing of insulin over an extended period, addressing the challenges of traditional insulin delivery methods such as manual injections or bulky external pumps. The system may incorporate sensors to monitor glucose levels and adjust insulin delivery in real-time, ensuring optimal therapeutic outcomes. The wearable nature of the device enhances patient convenience and compliance by eliminating the need for frequent manual interventions. Additionally, the system may include safety features to prevent overdosage or malfunction, such as automated shut-off mechanisms or user alerts. The invention aims to improve diabetes management by providing a discreet, efficient, and user-friendly insulin delivery solution.
10. The method of on-body fluid delivery of claim 1 , further comprising the steps of: entering a primary user interface SLEEP mode by the primary user interface and the primary patch pump; entering a primary user interface WAKE mode by the primary user interface at predetermined primary user interface WAKE time intervals; and entering a primary patch pump WAKE mode by the primary patch pump at predetermined primary patch pump WAKE time intervals, wherein a power level associated with the primary user interface SLEEP mode is lower than a power level associated with a primary user interface WAKE mode, and wherein a power level associated with the primary patch pump SLEEP mode is lower than a power level associated with a primary patch pump WAKE mode.
This invention relates to an on-body fluid delivery system, specifically a patch pump, designed to optimize power consumption by implementing sleep and wake modes for both the primary user interface and the primary patch pump. The system addresses the challenge of conserving battery life in wearable medical devices while ensuring reliable operation and user interaction. The primary user interface and the primary patch pump each operate in two distinct power states: a low-power SLEEP mode and a higher-power WAKE mode. The primary user interface periodically transitions from SLEEP mode to WAKE mode at predetermined intervals to check for user input or system updates, then returns to SLEEP mode to conserve power. Similarly, the primary patch pump wakes at scheduled intervals to perform necessary functions, such as delivering fluid or monitoring system status, before returning to SLEEP mode. The wake intervals for the user interface and the patch pump may be independently configured to balance responsiveness and power efficiency. By dynamically adjusting power states, the system extends battery life without compromising functionality. The user interface remains accessible for adjustments or alerts, while the pump ensures continuous, precise fluid delivery. This approach is particularly useful for long-term wearable medical devices, such as insulin pumps or continuous drug delivery systems, where power efficiency is critical.
11. The method of on-body fluid delivery of claim 10 , wherein at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump.
This invention relates to on-body fluid delivery systems, specifically improving synchronization between a primary user interface and a primary patch pump. The technology addresses the challenge of coordinating cycles between these components to ensure reliable and efficient fluid delivery. The primary user interface and the primary patch pump each operate in distinct cycles: SLEEP, WAKE, and SNIFF. The SLEEP cycle conserves power by reducing activity, the WAKE cycle activates the device for operation, and the SNIFF cycle checks for communication or status updates. The invention synchronizes at least one of these cycles between the user interface and the patch pump to optimize performance. For example, the user interface may wake up at the same time as the patch pump to exchange data, or both may enter a sleep state simultaneously to minimize power consumption. This synchronization ensures timely communication, reduces power usage, and enhances the overall reliability of the fluid delivery system. The invention is particularly useful in medical devices where precise timing and energy efficiency are critical.
12. The method of on-body fluid delivery of claim 10 , wherein if the primary user interface is engaged for an adjustment of basal rate or a setting of bolus delivery, after the adjustment or setting at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary user interface is synchronized with at least one of a SLEEP cycle, a WAKE cycle and a SNIFF cycle of the primary patch pump.
This invention relates to an on-body fluid delivery system, specifically a patch pump with a primary user interface for adjusting basal rates or setting bolus deliveries. The system addresses the challenge of ensuring synchronization between the user interface and the patch pump during adjustments to prevent errors or miscommunications. When a user engages the primary user interface to modify the basal rate or bolus delivery settings, the system synchronizes the operational cycles of the interface with those of the patch pump. These cycles include SLEEP, WAKE, and SNIFF modes, which manage power consumption, communication, and responsiveness. Synchronization ensures that adjustments are accurately processed and executed without delays or conflicts. The primary user interface may be a separate device that communicates wirelessly with the patch pump, allowing for remote adjustments while maintaining reliable synchronization. The patch pump itself is an on-body device designed for continuous or intermittent fluid delivery, such as insulin for diabetes management. The synchronization mechanism prevents data loss or misalignment between the interface and the pump, improving safety and reliability in fluid delivery.
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April 21, 2020
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